Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator

K-Number: K170990 · 2017-05-11

ApplicantSpiration, Inc.
Decision Date2017-05-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is a medical device manufactured by Spiration, Inc.. It received FDA 510(k) clearance on 2017-05-11 under approval number K170990. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Spiration, Inc.. The 510(k) number is K170990.

When was Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator approved by the FDA?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator received FDA 510(k) clearance on 2017-05-11, under approval number K170990.

What company makes Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is manufactured by Spiration, Inc..

What is the FDA product code for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator?

The FDA product code for Active Needle Endoscopic Treatment (ANET) Electrosurgical Applicator is GEI.

Related Clinical Trials

NCT05341661 Butterfly Pivotal Study ACTIVE_NOT_RECRUITING NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT06577454 Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Substance Use Disorder SUSPENDED NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING

Related PubMed Literature

PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025) PMID: 40826904 Why we should be prioritizing the average treatment effect on the treated over other estimands when evaluating drug and device safety. American journal of epidemiology (2025)

Other Devices by Spiration, Inc.

K152922ViziShot FLEX K171492B7 2C Occlusion Balloon K162611PeriFLEX

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑